FDA Approves Pediatric Hepatitis C Treatments

U.S FDA

Friday, the U.S FDA approved Harvoni and Sovaldi as a Hepatitis C treatments for kids 12-17. Sovaldi and Harvoni are typically only for adults in the United States. Due to the change it will be available for children.

The Hepatitis C treatments

Are the first antiviral medications available for children with HCV . Direct-acting medications prevent the virus from multiplying and reduce the amount of HCV in the body. In most cases, the HCV treatments can fully cure HCV.

Director of Antimicrobial Products at the FDA, Edward Cox, says the approval changes the HCV treatment landscape by bringing light to the needs being unmet in children.

Now, the approval gives pediatrics the options to treat six main genotypes of HCV. Sovaldi along with Ribavirin is used to treat children 12 and older with type 2 and 3 HCV. Harvoni is used for children 12 and older with type 1, 4, 5, and 6 HCV. Both treatments are for those without cirrhosis or with a mild form of cirrhosis.

HCV is a virus causing inflammation in the liver. Furthermore the disease can deteriorate the liver and cause liver failure. The CDC estimates that 2.7-3.9 million Americans have HCV. Children born with HCV from their mothers are at high risk for infection. There are up to 46,000 U.S children with HCV.

Harvoni & Sovaldi

The Harvoni trial consists of 100 pediatric patients with type 1 HCV compared to adult patients. It shows that after 12 weeks, 98% had no virus in the blood. Meaning the infections were cure completely. The most common side effects during the trials were a headache and fatigue.

The Sovaldi trials in combination with Ribavirin consists of 50 pediatric patients compared to adults. 100% of patients with type 2 and 97% of patients with type 3 had no virus after 12 weeks of treatment. Sovaldi side effects were also a headache and fatigue.

Sovaldi and Harvoni are medicines that Gilead Sciences, Inc. Makes

The FDA assures safety and protects the health of the public through security of veterinary and human drugs, vaccines, and ensuring the effectiveness of medical devices and human use. Yet they are also responsible for the security and safety of our country’s cosmetics, dietary supplements, tobacco, and our food supply.